Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide together with etanercept and to see how well it works in treating patients with myelodysplastic syndromes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Etanercept

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndromes (MDS) meeting 1 of the following criteria:

• Intermediate-2 or high-risk disease

• Intermediate-1 or low-risk disease that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872

• Not eligible for stem cell transplantation for any of the following reasons:

• Suitable bone marrow donor is not available

• Ineligible for a transplantation protocol

• Not willing to undergo transplantation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 500/mm^3

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No evidence of cardiac arrhythmia

• No evidence of congestive heart failure

• QTc interval ≤ 460 msec

Pulmonary

• No pneumonia

Other

• Potassium > 4.0 mEq/L (supplemental electrolytes allowed)

• Magnesium > 1.8 mg/dL (supplemental electrolytes allowed)

• No history of anaphylactic reaction to arsenic trioxide

• No active severe infection (e.g., septicemia) within the past 2 weeks

• No other severe disease that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• No prior hematopoietic stem cell transplantation

• More than 4 weeks since prior hematopoietic growth factors for MDS

• More than 4 weeks since prior immunomodulatory therapy for MDS

• No concurrent hematopoietic growth factors for MDS

• No other concurrent immunomodulatory therapy for MDS

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since prior cytotoxic therapy for MDS

• More than 4 weeks since prior experimental therapy for MDS

• No other concurrent cytotoxic therapy for MDS

• No other concurrent experimental therapy for MDS